WO2011043086A1 - マイクロニードルスタンパーの製造方法 - Google Patents
マイクロニードルスタンパーの製造方法 Download PDFInfo
- Publication number
- WO2011043086A1 WO2011043086A1 PCT/JP2010/050409 JP2010050409W WO2011043086A1 WO 2011043086 A1 WO2011043086 A1 WO 2011043086A1 JP 2010050409 W JP2010050409 W JP 2010050409W WO 2011043086 A1 WO2011043086 A1 WO 2011043086A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- stamper
- base material
- microneedle
- original plate
- needle
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0046—Solid microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0053—Methods for producing microneedles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C59/00—Surface shaping of articles, e.g. embossing; Apparatus therefor
- B29C59/02—Surface shaping of articles, e.g. embossing; Apparatus therefor by mechanical means, e.g. pressing
Definitions
- the present invention relates to a female mold manufacturing method for manufacturing a microneedle for injecting a drug from the skin.
- the length of the microneedle is about several hundreds of micrometers, so there is almost no colic. Further, when the sheet is removed from the skin, the microneedle portion is formed of a self-dissolving substance so that even if the microneedle remains in the skin, the human body is not affected.
- the original 90 of the microneedle sheet is produced by a method such as micromachining, vacuum processing, or photolithography.
- the length 93 of the needle has a cone shape of several hundred ⁇ m or less. Cross sections include circles, corners, and ellipses. Since the needle has a very small size, it is preferable to cut the needle 92 from the original plate 91 and form it.
- the master 90 is pressed against the stamper base material 81 to produce a stamper 80 (microneedle sheet mold). Then, a resin solution or a drug 85 is poured into the stamper 80, and after drying, the microneedle sheet 77 can be obtained by attaching to the fixing substrate 88 and transferring it by peeling (see Patent Document 1).
- the tip Since the microneedle penetrates into the skin, the tip must be as sharp as possible. Then, the microneedle sheet is produced by pouring a needle material into the produced stamper. Therefore, the bottom of the recess of the stamper into which the raw material is poured (corresponding to the tip of the microneedle) must be a recess with high sharpness. However, there is a problem that it is not easy to form a dent with high sharpness in the base material.
- the concave portion of the stamper has a very small size. Therefore, there is a problem that the raw material of the microneedle is not easily filled into the concave portion of the stamper due to air or surface tension.
- Patent Documents 2 and 3 discloses that when a raw material is filled in a stamper, it is performed in a reduced pressure state. Further, Patent Document 3 discloses that pressurization is performed from the raw material side to fill the concave portion of the stamper.
- Patent Document 2 discloses that when a large number of microneedles are arranged, there is a problem that some microneedles may not be formed because raw materials are not filled in some recesses.
- the present invention has been conceived in view of the above problems, and specifically, Heating the original plate having a sheet-like base material and conical projections; Inserting a projection of the original plate into the base material to form a conical recess; Cooling the original while the base material is inserted; Releasing the original plate from the base material; A stamper manufacturing method including the step of heating the base material is provided.
- the manufacturing method of the stamper of the present invention In the step of forming the conical recess, The projection of the original plate is inserted until it penetrates the base material.
- a master plate having a conical protrusion is inserted into a warmed stamper member to provide a conical concave portion, which is cooled as it is and released from the mold, so that stress remains in the stamper member deformed by the conical protrusion.
- a recess is formed as it is.
- a through-hole penetrating to the opposite surface of the stamper is formed in the bottom of the recess in advance and the stamper member is re-deformed by the above method, a fine through-hole can be formed. Even if air is accumulated in the concave portion of the stamper having the minute through hole when the microneedle member is applied, the air easily escapes. Accordingly, the raw material can be filled in the recesses of all the stampers, and a microneedle sheet can be obtained in which all the planned numbers of microneedles are formed.
- stamper of this invention It is the schematic of the stamper of this invention. It is a figure which shows the manufacturing process of the stamper of this invention. It is a figure which shows the detail of the manufacturing process of the stamper of this invention. It is a figure which shows the manufacturing process of the macroneedle sheet
- FIG. 1 shows a stamper 1 of a microneedle sheet according to the present invention.
- the stamper 1 is a sheet-like base material 2 having a conical recess 3 formed therein.
- the material of the base material 2 is not particularly limited, but since it is a pharmaceutical, a material that does not easily cause contamination (contamination) or a material that does not affect the human body is preferable.
- the stamper 1 of the present invention forms a concave shape having a tip with high sharpness by heat shrinkage, plastics such as PTFE, polypropylene, and polyethylene are preferably used.
- a through hole 4 penetrating the other surface of the base material is formed at the bottom of the recess 3. Since the through-hole 4 becomes a part forming the tip of the microneedle, the diameter is preferably small. Functionally, it is only necessary that the air accumulated in the concave portion is released so that the raw material is filled in the concave portion 3, and it is not always necessary to have a hole having a finite length. That is, as long as air is released when pressure is applied, it may appear to be normally closed. Specifically, it is preferably 10 or more microns or less.
- the installation density and installation distribution of the microneedles are not particularly limited, and may be determined as needed depending on the application and purpose.
- a stamper for producing a microneedle sheet having four microneedles will be described.
- the original plate 10 is a flat main body 11 formed with conical protrusions 12.
- the material is not particularly limited, but a metal excellent in workability can be suitably used.
- the base material is heated to near the softening point temperature, a material that can maintain the hardness at such a temperature is preferable.
- the conical protrusions are minute, a material with high machinability is preferable.
- copper, aluminum, nickel, silicon, etc. can be used.
- the protrusion 12 may be formed by a method using photolithography in addition to processing by cutting out from the main body 11.
- the protrusion 12 has a height 13 of about 1 ⁇ m to 600 ⁇ m on the main body 11.
- the epidermis into which drugs, etc. are injected using a microneedle sheet is formed of the stratum corneum, granule layer, spiny layer, and basal layer, but the stratum corneum differs in thickness depending on the part of the body. This is because the height of the microneedle may be changed depending on the body part and the drug.
- the cross-sectional shape is not particularly limited, and a circle, an ellipse, a square including a square, or the like is preferably applied.
- channel may be formed in the protrusion surface. This is because the microneedle reflecting the groove shape may be able to be smoothly inserted into the skin.
- the thickness 5 of the base material 2 is thinner than the length 13 of the protrusion 12. This is because the tip of the protrusion 12 penetrates the base material 2 to form the through hole 4.
- the diameter of the through hole 4 formed in the base material 2 can be set from the tip shape of the protrusion 12 and the thickness 5 of the base material 2 so as to be about several tens of microns.
- the through-hole 4 can be contracted by thermal contraction, and therefore the through-diameter 4 a when the projection 12 of the original plate 10 penetrates the base material 2 may be several times larger than the through-hole 4 of the stamper 1. is there.
- the master 10 and the base material 2 are heated 14 in advance.
- the heating temperature is lower than the melting temperature of the base material 2.
- a temperature near the softening point temperature of the base material 2 is preferable. This is because the formation of the concave portion of the stamper according to the present invention undergoes a process of plastic deformation while leaving stress on the base material 2. If the temperature of the original plate 10 is higher than the melting temperature of the base material 2, the base material 2 is melted, and the recess 3 along the shape of the protrusion 12 of the original plate 10 cannot be formed. Further, if the temperature of the original plate 10 is too low as compared with the temperature of the base material 2, stress necessary for re-deformation does not remain.
- FIG. 3A shows an enlarged view of a portion where the protrusion 12 of the heated original plate 10 is pierced by the heated base material 2.
- the base material is pushed and spread by the protrusions 12, so that the molecules are compressed. This compressed portion is referred to as a concave surface layer 26.
- the base material 2 from which the original plate 10 has been released is heated again.
- the heating temperature is in the vicinity of the softening point temperature and is preferably equal to or lower than the melting temperature. This is because if the temperature is within this range, deformation can be achieved by releasing the stress of the concave surface layer.
- the through hole shrinks and a concave portion with high sharpness can be formed. Furthermore, the diameter (4a ⁇ ) of the through hole becomes smaller (4 ⁇ ) due to the shrinkage than in the case where the original plate of FIG.
- the base material 2 is polyethylene and is held at 90 ° C. for about 10 seconds, the through hole can be contracted to a diameter of 40 ⁇ m to 10 ⁇ m, and a micro microneedle can be produced.
- a microneedle sheet is produced with the stamper produced as described above.
- the microneedle sheet is produced by applying needle material 20 to stamper 1 (FIG. 4 (a)).
- the needle raw material 20 it is preferable to use a material that is discharged without remaining in the body.
- the needle part may break or come off and not all be recovered. This is because any material that can be absorbed by the body is safe.
- a material mainly composed of a leaky substance or the like is preferable.
- a drug may be mixed in the needle raw material in advance.
- the drug is a pure chemical substance having a physiological activity, and includes peptide protein drugs such as insulin, growth hormone, erythropoietin, interferon, vaccine antigen, antigen protein, polymer drug, vitamin C, and the like.
- peptide protein drugs such as insulin, growth hormone, erythropoietin, interferon, vaccine antigen, antigen protein, polymer drug, vitamin C, and the like.
- the thing which has these as a main component may be sufficient.
- the needle material is injected into the stamper only by coating, and the needle material is recessed. To be filled. That is, even if there is air 72 at the bottom of the recess 3 of the stamper 1, it is easily discharged through the through hole 4, and the needle material is filled in the recess 3.
- pressurization 15 may be performed after coating (FIG. 4B). If pressure is applied, the air accumulated at the bottom of the recess 3 of the stamper can be extracted more easily.
- the stamper 1 may be disposed on the flat table 18 formed of a porous solid, and the needle raw material 20 may be applied while applying the negative pressure 16 from the back surface of the flat table 18 (see FIG. 4B). Also in this case, the needle raw material 20 can be easily injected into the recess 3 of the stamper. Further, it is better if pressure 15 is applied from the upper surface of the flat table 18 and negative pressure 16 is applied from the rear surface.
- the needle material 20 After the needle material 20 is applied to the stamper 1, it is dried and peeled off from the stamper to complete the microneedle sheet 30 (see FIG. 4 (d)).
- the fixed base 88 is attached from the back surface of the dried needle material 20 and peeled off from the stamper. If the drug is not charged in the microneedle sheet 30 peeled from the stamper, the drug is sprayed on the needle portion 31 after peeling from the stamper.
- the stamper of the present invention has a minute through-hole penetrating to the opposing surface of the stamper at the bottom of the recess forming the needle, so that even if air enters the recess, it can be easily removed. It is possible to obtain a microneedle sheet capable of producing a high needle.
- the present invention can be widely used not only for a microneedle sheet for injecting a drug into the epidermis, but also for a method for generating microprojections on a substrate.
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Dermatology (AREA)
- Medical Informatics (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Moulds For Moulding Plastics Or The Like (AREA)
- Micromachines (AREA)
Abstract
Description
シート状の母材と錐状の突起を有する原版を加熱する工程と、
前記原版の突起を前記母材に挿入して錐状凹部を形成する工程と、
前記原版を前記母材の挿入したまま冷却する工程と、
前記原版を前記母材から離型する工程と、
前記母材を加熱する工程を有するスタンパーの製造方法を提供する。
前記錐状凹部を形成する工程では、
前記原版の突起は前記母材を貫通するまで挿入されることを特徴とする。
図1に本発明のマイクロニードルシートのスタンパー1を示す。スタンパー1はシート状の母材2に錐状の凹部3が形成されたものである。母材2の材質は特に限定されるものではないが、医薬品であるため、コンタミネーション(汚染)が出にくい材質または人体に影響のない材質が良い。また、本発明のスタンパー1は、熱収縮によって尖鋭度の高い先端を有する凹部形状を形成するので、PTFE、ポリプロピレン、ポリエチレンなどのプラスチックが好適に用いられる。
2 母材
3 凹部
4 貫通孔
5 母材厚み
10 原版
11 原版本体
12 突起
13 突起高さ
14 加熱
15 圧力
16 陰圧
18 多孔質固体の平面台
20 ニードル原料
26 凹部表面層
27 応力
28 凹部表面層の移動方向
30 マイクロニードルシート
31 ニードル
72 空気
77 マイクロニードルシート
80 従来のスタンパー
81 従来のスタンパー母材
85 ニードル原料
88 固定基材
90 原版
91 本体
92 突起
93 突起の長さ
Claims (2)
- シート状の母材と錐状の突起を有する原版を加熱する工程と、
前記原版の突起を前記母材に挿入して錐状凹部を形成する工程と、
前記原版を前記母材の挿入したまま冷却する工程と、
前記原版を前記母材から離型する工程と、
前記母材を加熱する工程を有するスタンパーの製造方法。 - 前記錐状凹部を形成する工程では、
前記原版の突起は前記母材を貫通するまで挿入される請求項1に記載されたスタンパーの製造方法。
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/674,745 US20110127690A1 (en) | 2009-10-08 | 2010-01-15 | Stamper For Microneedle Sheet, Production Method Thereof, And Microneedle Production Method Using Stamper |
EP10703213A EP2343102A4 (en) | 2009-10-08 | 2010-01-15 | METHOD FOR MANUFACTURING A MATRIX FOR MICRO NEEDLE |
CN201080000607XA CN102202724A (zh) | 2009-10-08 | 2010-01-15 | 微针压模的制造方法 |
CA2696810A CA2696810A1 (en) | 2009-10-08 | 2010-01-15 | Method for producing stamper for microneedle |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2009-234110 | 2009-10-08 | ||
JP2009234110A JP5542404B2 (ja) | 2009-10-08 | 2009-10-08 | マイクロニードルスタンパーの製造方法 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2011043086A1 true WO2011043086A1 (ja) | 2011-04-14 |
Family
ID=43857779
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2010/050409 WO2011043086A1 (ja) | 2009-10-08 | 2010-01-15 | マイクロニードルスタンパーの製造方法 |
Country Status (9)
Country | Link |
---|---|
US (1) | US20110127690A1 (ja) |
EP (1) | EP2343102A4 (ja) |
JP (1) | JP5542404B2 (ja) |
KR (1) | KR20110067009A (ja) |
CN (1) | CN102202724A (ja) |
AU (1) | AU2010201434A1 (ja) |
CA (1) | CA2696810A1 (ja) |
TW (1) | TW201113057A (ja) |
WO (1) | WO2011043086A1 (ja) |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1602623B1 (en) * | 2003-03-07 | 2011-08-17 | Tosoh Corporation | Method of moulding a microfluidic structure and mould |
CN103301563B (zh) * | 2013-06-20 | 2016-03-23 | 吴传斌 | 可溶性同轴锥多层微针、微针阵列及其制备方法 |
KR101663805B1 (ko) * | 2014-12-03 | 2016-10-14 | 연세대학교 산학협력단 | 마이크로 니들이 형성된 풍선도관 및 그 제작방법 |
JP2016189844A (ja) * | 2015-03-31 | 2016-11-10 | 日本写真印刷株式会社 | マイクロニードルパッチ |
KR101676861B1 (ko) | 2015-04-10 | 2016-11-17 | 씨앤텍 주식회사 | 마이크로 니들 패치 제조장치와 방법, 및 이에 의해 제조되는 마이크로 니들 패치 |
WO2017003760A1 (en) * | 2015-06-30 | 2017-01-05 | The Gillette Company Llc | Polymeric cutting edge structures and method of manufacturing thereof |
EP3357862B1 (en) | 2015-09-30 | 2020-03-04 | FUJIFILM Corporation | Mould fabrication method, patterned sheet production method, electroformed mould fabrication method, and mould fabrication method using electroformed mould |
KR101636070B1 (ko) * | 2015-12-30 | 2016-07-14 | 주식회사 라파스 | 마이크로니들 제조장치 |
JP2017131397A (ja) * | 2016-01-27 | 2017-08-03 | 花王株式会社 | 微細中空突起具の製造方法 |
US11266344B2 (en) | 2016-09-21 | 2022-03-08 | Samsung Electronics Co., Ltd. | Method for measuring skin condition and electronic device therefor |
CN109604417B (zh) * | 2018-10-03 | 2024-03-19 | 淮北宇光纺织器材有限公司 | 一种半弧形齿顶金属针布冲齿装置 |
TWI724837B (zh) * | 2020-03-25 | 2021-04-11 | 映通股份有限公司 | 用以形成微針產品之模具結構 |
JP7008854B1 (ja) | 2021-03-30 | 2022-01-25 | リンテック株式会社 | マイクロニードルの製造方法およびマイクロニードルの製造装置 |
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JP2007044831A (ja) * | 2005-08-11 | 2007-02-22 | Aitesu:Kk | ナノインプリント用金型の製造方法 |
JP2008542081A (ja) * | 2005-06-10 | 2008-11-27 | オブデュキャット、アクチボラグ | 中間スタンプによるパターン複製 |
JP2009061219A (ja) * | 2007-09-10 | 2009-03-26 | Kagawa Univ | 微小針の製造方法 |
JP2009083125A (ja) * | 2007-09-27 | 2009-04-23 | Fujifilm Corp | 機能性膜の製造方法および製造装置 |
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US5252279A (en) * | 1991-01-17 | 1993-10-12 | Reinhold Industries | Method for making perforated articles |
US7497980B2 (en) * | 2003-11-10 | 2009-03-03 | Agency For Science, Technology And Research | Microneedles and microneedle fabrication |
GB0600795D0 (en) * | 2006-01-16 | 2006-02-22 | Functional Microstructures Ltd | Method of making microneedles |
JP4265696B2 (ja) * | 2006-07-04 | 2009-05-20 | 凸版印刷株式会社 | マイクロニードルの製造方法 |
-
2009
- 2009-10-08 JP JP2009234110A patent/JP5542404B2/ja active Active
-
2010
- 2010-01-15 AU AU2010201434A patent/AU2010201434A1/en not_active Abandoned
- 2010-01-15 WO PCT/JP2010/050409 patent/WO2011043086A1/ja active Application Filing
- 2010-01-15 KR KR1020107004177A patent/KR20110067009A/ko not_active Application Discontinuation
- 2010-01-15 CA CA2696810A patent/CA2696810A1/en not_active Abandoned
- 2010-01-15 CN CN201080000607XA patent/CN102202724A/zh active Pending
- 2010-01-15 EP EP10703213A patent/EP2343102A4/en not_active Withdrawn
- 2010-01-15 US US12/674,745 patent/US20110127690A1/en not_active Abandoned
- 2010-02-24 TW TW099105235A patent/TW201113057A/zh unknown
Patent Citations (4)
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JP2008542081A (ja) * | 2005-06-10 | 2008-11-27 | オブデュキャット、アクチボラグ | 中間スタンプによるパターン複製 |
JP2007044831A (ja) * | 2005-08-11 | 2007-02-22 | Aitesu:Kk | ナノインプリント用金型の製造方法 |
JP2009061219A (ja) * | 2007-09-10 | 2009-03-26 | Kagawa Univ | 微小針の製造方法 |
JP2009083125A (ja) * | 2007-09-27 | 2009-04-23 | Fujifilm Corp | 機能性膜の製造方法および製造装置 |
Non-Patent Citations (1)
Title |
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See also references of EP2343102A4 * |
Also Published As
Publication number | Publication date |
---|---|
US20110127690A1 (en) | 2011-06-02 |
TW201113057A (en) | 2011-04-16 |
AU2010201434A1 (en) | 2011-05-12 |
CA2696810A1 (en) | 2011-02-10 |
KR20110067009A (ko) | 2011-06-20 |
JP5542404B2 (ja) | 2014-07-09 |
JP2011078618A (ja) | 2011-04-21 |
EP2343102A1 (en) | 2011-07-13 |
CN102202724A (zh) | 2011-09-28 |
EP2343102A4 (en) | 2012-09-26 |
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